Pharmacokinetic profile of a 24-hour controlled-release OROS？ formulation of hydromorphone in the presence and absence of food 英文参考文献.docVIP

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Pharmacokinetic profile of a 24-hour controlled-release OROS？ formulation of hydromorphone in the presence and absence of food 英文参考文献.doc

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Pharmacokinetic profile of a 24-hour controlled-release OROS？ formulation of hydromorphone in the presence and absence of food 英文参考文献

BMC Clinical Pharmacology BioMedCentral Research article Open Access Pharmacokinetic profile of a 24-hour controlled-release OROS? formulation of hydromorphone in the presence and absence of food Gayatri Sathyan*, Emily Xu, John Thipphawong and Suneel K Gupta Address: ALZA Corporation, Mountain View, CA, USA Email: Gayatri Sathyan* - gsathyan@; Emily Xu - Exu@; John Thipphawong - jthippha@; Suneel K Gupta - sgupta7@ * Corresponding author Published: 2 February 2007 Received: 4 May 2006 Accepted: 2 February 2007 BMC Clinical Pharmacology 2007, 7:2 doi:10.1186/1472-6904-7-2 This article is available from: /1472-6904/7/2 ? 2007 Sathyan et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: The objective of this study was to compare the pharmacokinetic profile of a novel, once-daily, controlled-release formulation of hydromorphone (OROS? hydromorphone) under fasting conditions with that immediately after a high-fat breakfast in healthy volunteers. The effect of the opioid antagonist naltrexone on fasting hydromorphone pharmacokinetics also was evaluated. Methods: In an open-label, three-way, crossover study, 30 healthy volunteers were randomized to receive a single dose of 16 mg OROS? hydromorphone under fasting conditions, 16 mg OROS? hydromorphone under fed conditions, or 16 mg OROS? hydromorphone under fasting conditions with a naltrexone 50-mg block. Plasma samples taken pre-dose and at regular intervals up to 48 hours post-dose were assayed for hydromorphone concentrations. Analysis of variance was performed on log-transformed data; for mean ratios of 0.8 to 1.2 (20%), differences were considered minimal. Bioequivalence was reached if 90% c